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First received: March 13, 2023

Clinical Trial: Study to Assess Adverse Events, Change in Disease Activity, and How Oral Upadacitinib Moves Through the Body of Pediatric Participants With Moderately to Severely Active Ulcerative Colitis.

Study Status: Completed

Recruit Status: RECRUITING

Condition: Ulcerative Colitis

Study Type: INTERVENTIONAL


Official Title: A Phase 3 Multicenter Study to Evaluate Efficacy, Safety, and Pharmacokinetics of Upadacitinib With Open-Label Induction, Randomized, Double-Blind Maintenance and Open-Label Long-Term Extension in Ped

Brief Summary: Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).This study will assess how safe and effective Upadacitinib is in treating pediatric participants with UC.Adverse events and change in disease activity will be assessed.Upadacitinib (RINVOQ) is a drug approved in adults for moderate- to severely active UC and is being developed for moderate- to severely active UC in pediatric participants.This study is…

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